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Micro SSP Generic HLA Class I DNA Typing Trays (2014-11-26)
- Starting date:
- November 26, 2014
- Posting date:
- December 29, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43049
Recalled Products
Micro SSP Generic HLA Class I DNA Typing Trays
Reason
Allele information on the lot specific user document, SSP-001l-010-WS-00 revision 0 (worksheet) is missing and may cause incorrect typing information for analysis completed manually. Typing analysis using HLA fusion software is not impacted by this issue.
Affected products
Micro SSP Generic HLA Class I DNA Typing Trays
Lot or serial number
010 batches 001-006
Model or catalog number
SSP1L
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES